Method and device for intracochlea impedance measurement

ABSTRACT

This method of determining an intracochlea tissue impedance comprises using at least two stimulating electrodes to apply an electrical stimulus to intracochlea tissue. A voltage caused by the stimulus is measured between two measuring electrodes distinct from the stimulating electrodes. From the voltage a stimulus-response characteristic of tissue between the two measuring electrodes is determined. This allows the tissue/electrode interface impedance and potential and the tissue impedance and potential to be uniquely determined. In turn, modiolus currents can be estimated in monopolar stimulation mode. Also provided is automated initiation of re-mapping of the device when tissue characteristics change.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a divisional application of U.S. patent applicationSer. No. 12/675,969, filed on Dec. 23, 2010, entitled “METHOD AND DEVICEFOR INTRACOCHLEA IMPEDANCE MEASUREMENT,” which is a National StageApplication of International Patent Application No. PCT/AU2008/001253,filed Aug. 25, 2008, entitled “METHOD AND DEVICE FOR INTRACOCHLEAIMPEDANCE MEASUREMENT,” which claims priority from AustralianProvisional Patent Application No. 2007904682, filed Aug. 29, 2007 andAustralian Provisional Patent Application No. 2008903936, filed Jul. 31,2008. The contents of these applications are hereby incorporated byreference herein.

BACKGROUND

Field of the Invention

The present invention relates to measurement of electricalcharacteristics of tissue subjected to electrical stimulation by acochlear implant.

Related Art

Cochlear implant systems bypass the hair cells in the cochlea anddirectly deliver electrical stimulation to the auditory nerve fibers,thereby allowing the brain to perceive a hearing sensation resemblingthe natural hearing sensation normally delivered to the auditory nerve.U.S. Pat. No. 4,532,930, the content of which is incorporated herein byreference, provides a description of one type of traditional cochlearimplant system.

Cochlear implant systems have typically consisted of an externalcomponent referred to as a processor unit and an internal implantedcomponent referred to as a stimulator/receiver unit. These componentscooperate to provide the sound sensation to a user.

The external component has a microphone for detecting sounds, such asspeech and environmental sounds, a speech processor that converts thedetected sounds into a coded signal, a power source such as a battery,and an external transmitter coil.

The coded signal output by the speech processor is transmittedtranscutaneously to the implanted stimulator/receiver unit situatedwithin a recess of the temporal bone of the user. This transcutaneoustransmission occurs via the external transmitter coil which ispositioned to communicate, generally via RF, with an implanted receivercoil provided with the stimulator/receiver unit. This communicationserves two purposes, firstly to transcutaneously transmit the codedsound signal and secondly to provide power to the implantedstimulator/receiver unit.

The implanted stimulator/receiver unit includes a receiver coil thatreceives the coded signal and power from the external processorcomponent, and a stimulator that processes the coded signal and outputsa stimulation signal to an intracochlea electrode assembly or array. Theelectrode array applies the electrical stimulation directly to theauditory nerve producing a hearing sensation corresponding to theoriginal detected sound.

Following implantation, and at subsequent times as physiological changesoccur, there is a need to determine the actual performance of theelectrode array and the response of the auditory nerve to stimulation.Data collection for this purpose enables detection and confirmation ofthe normal operation of the device, and allows stimulation parameters tobe optimized to suit the characteristics of the patient. This procedurecan include determination of patient specific parameters such asthreshold levels (T levels) and maximum comfort levels (C levels) foreach stimulation channel. Such data collection can be performed manuallyin a clinical setting by relying on subjective recipient responses, orby taking measurements directly from the cochlea such as by recording aneural response to stimulation in the manner set out in InternationalPatent Publication No. WO 02/082982, the content of which isincorporated herein by reference. Users' T and C levels vary over timewhether permanently such as in the case of tissue degradation, ortemporarily for example in the case of the user having a short termdisease. For optimal device function it is therefore important toclinically re-fit the device at regular intervals, however this is laborintensive.

Impedance measurements may also be made of the cochlea tissue. Existingimpedance measurement techniques used in cochlear implant devices applya stimulus with an electrode pair, and measure the voltage across thatelectrode pair. Such an impedance measurement provides information aboutthe total impedance between the two stimulating electrodes, which can beuseful to determine the functional condition of the implant. However,the voltage measured arises not only from the tissue impedance betweenthe electrodes, but also from the electrode/tissue interface impedanceat each electrode. The electrode/tissue interface impedance depends onthe condition and the size of the electrode contact surface area and theamplitude of the stimulation current. The electrode/tissue interfaceimpedance dominates and masks the tissue impedance. It is thereforedifficult to precisely determine the tissue impedance and the biologicalcondition of the tissue from such voltage measurements.

Any discussion of documents, acts, materials, devices, articles or thelike which has been included in the present specification is solely forthe purpose of providing a context for the present invention. It is notto be taken as an admission that any or all of these matters form partof the prior art base or were common general knowledge in the fieldrelevant to the present invention as it existed before the priority dateof each claim of this application.

Throughout this specification the word “comprise”, or variations such as“comprises” or “comprising”, will be understood to imply the inclusionof a stated element, integer or step, or group of elements, integers orsteps, but not the exclusion of any other element, integer or step, orgroup of elements, integers or steps.

SUMMARY

In one aspect of the present invention, a method determining anintracochlea tissue impedance is provided. The method comprises applyingan electrical stimulus to intracochlea tissue with at least twostimulating electrodes; measuring a voltage caused by the stimulusbetween two measuring electrodes distinct from the stimulatingelectrodes; and determining from the voltage a stimulus-responsecharacteristic of tissue between the two measuring electrodes.

In a second aspect of the present invention, a cochlear implant systemfor determining an intracochlea tissue impedance is provided. Thecochlear implant system comprises an implantable electrode arraycomprising a plurality of electrodes for applying electrical stimuli tointracochlea tissue; and a controller adapted to cause application of anelectrical stimulus to intracochlea tissue by at least two stimulatingelectrodes, to cause measurement of a voltage caused by the stimulusbetween two measuring electrodes distinct from the at least twostimulating electrodes, and to determine from the voltage astimulus-response characteristic of tissue between the two measuringelectrodes.

In a third aspect of the present invention, a method of measuring atissue response arising from a stimulus is provided. The methodcomprises applying an electrical stimulus to the tissue using at leasttwo stimulating electrodes; after the stimulus, open circuiting thestimulating electrodes and measuring a residual two point potentialbetween the stimulating electrodes; after the stimulus, measuring aresidual potential between two non-stimulating electrodes, referred toas a residual four point potential; and comparing the measured two pointpotential to the measured four point potential to determine at least oneof a residual tissue potential and a residual electrode/tissue interfacepotential.

In a fourth aspect of the present invention, a cochlear implant systemfor measuring a tissue response arising from a stimulus is provided. Thecochlear implant system comprises an implantable electrode arraycomprising a plurality of electrodes for applying Metrical stimuli tointracochlea tissue; and a controller adapted to apply an electricalstimulus to the tissue using at least two stimulating electrodes; afterthe stimulus, open circuit the stimulating electrodes and measuring aresidual two point potential between the stimulating electrodes; afterthe stimulus, measure a residual potential between two nonstimulatingelectrodes, referred to as a residual four point potential; and comparethe measured two point potential to the measured four point potential todetermine at least one of a residual tissue potential and a residualelectrode/tissue interface potential.

In a fifth aspect of the present invention, a method for estimatingmodiolus currents induced in a cochlea by electrical stimulation isprovided. The method comprises determining an intra-cochlea tissueimpedance Z_(t1) between a first intracochlear electrode and a secondintra-cochlear electrode by a four point impedance measurement;determining an intra-cochlea tissue impedance Z_(t2) between the secondintra-cochlear electrode and a third intra-cochlear electrode by a fourpoint impedance measurement; while passing a current between a fourthintra-cochlear electrode and an extra-cochlear electrode, measuringrespective voltages V₁, V₂ and V₃ arising at the first, second and thirdintra-cochlear electrodes; determining respective intra-cochlea tissuecurrents I_(t1) and I_(t2) flowing through the intracochlea tissueimpedances Z_(t1) and Z_(t2) as being I_(t1)=(V₁−V₂)/Z_(t1) andI_(t2)=(V₂−V₃)/Z_(t2); and determining that a modiolus current I_(m2)arising in the proximity of the second electrode due to the currentbetween the fourth intra-cochlear electrode and the extra-cochlearelectrode is I_(m2)=I_(t2)−I_(t1).

In a final aspect of the present invention, a method of automatedinitiation of re-mapping of a cochlear implant is provided. The methodcomprises obtaining measurements of tissue response to electricstimulation; comparing the tissue response measurements with previouslyobtained tissue response measurements, to identify any changes whichhave occurred over time in the tissue response to stimulation; and uponidentification of a change in tissue response, initiating re-mapping ofthe cochlear implant.

BRIEF DESCRIPTION OF THE DRAWINGS

Illustrative embodiments of the present invention will now be aredescribed herein with reference to the accompanying FIGS., in which:

FIGS. 1a and 1b illustrate a system for four point impedance measurementin accordance with one embodiment of the invention;

FIG. 2 is an equivalent circuit of the cochlea when subjected tomonopolar stimulation;

FIGS. 3a and 3b respectively illustrate the voltage and currentdistributions along an electrode array in response to a monopolarstimulus;

FIG. 4 is a schematic diagram of a cochlear implant system forimplementing an embodiment of the present invention; and

FIG. 5 illustrates the shape of a current pulse used for cochlea neuronstimulation.

DETAILED DESCRIPTION

FIGS. 1a and 1b illustrate a system for four point impedance measurementin accordance with one embodiment of the invention. Two electrode pairsare used, selected from the electrodes of a cochlear implant electrodearray. As will be discussed in further detail below, in this embodimentthe voltage is measured between two measuring electrodes that are notused to apply the stimulus. This type of measurement is referred toherein as a four point measurement.

The current stimulation pair E_(a) and E_(d) are used to stimulate thecochlear tissue. The biphasic current path is as follows. During phase1, a constant stimulation current, set by the programmed current sourceCS, flows from the power supply rail V_(dd), through the associatedswitch of the chosen indifferent electrode to the power supply railS_(aA), the indifferent electrode E_(a), the intracochlea tissue, theactive electrode E_(d) and its associated switch S_(dB) to the currentsource. During phase 2, a constant stimulation current with the sameamplitude as in phase 1 flows from the power supply rail V_(dd), throughswitch S_(dA), the indifferent electrode Ed, the intracochlea tissue,the active electrode Ea and its associated switch S_(aB) to the currentsource CS.

A second electrode pair E_(b) and E_(c), being the voltage measurementpair, together with separate switching circuitry, are used to measurethe voltage arising from the biphasic stimulation applied by E_(a) andE_(d). The voltage difference between electrodes E_(b) and E_(c) dependsalmost solely on the tissue impedance between them, with the stimulationcurrent being constant.

Notably, while the E_(a) and E_(d) electrode/tissue interfaceimpedances, and the impedance of the switches S_(aA), S_(aB), S_(dB) andS_(dA) affect the current source output voltage, such impedances do notcontribute to the voltage measured between electrodes E_(b) and E_(c).

The E_(b) and E_(c) electrode/tissue interface impedances and theimpedance of the voltage switches S_(bv) and S_(cv) are in series withthe input impedance of the associated voltage measurement circuitry.However, as the input impedance of the voltage measurement circuitry isvery high and practically no current flows through it, closing switchesS_(bv) and S_(cv), places the measuring electrodes E_(b) and E_(c) in ahigh input impedance state during the four point measurement. Themeasured voltage thus arises almost entirely from the tissue voltagebetween electrodes E_(b) and E_(c), and does not depend on theirelectrode surface contact impedances and the impedance of the voltageswitches S_(bv) and S_(cv).

The polarity of the voltage measured at electrodes E_(b) and E_(c)reverses with the change in current direction between phase 1 and phase2. Accordingly, the input of the associated voltage measurementcircuitry is connected in a differential mode. The measured impedance(being the measured voltage difference between electrodes E_(b) andE_(c) divided by the stimulation current) is then the tissue impedancebetween electrodes E_(b) and E_(c).

The voltage measurement electrode pair E_(b) and E_(c) may be used fortwo-point impedance measurement, by disconnecting them from the voltagemeasurement circuitry (switches S_(bv) and S_(cv) “OFF”) as shown inFIG. 1b . Such a two-point impedance measurement obtains a measure ofthe sum of E_(b) and E0 electrode/tissue interface impedance and thetissue impedance between them. As the tissue impedance between E_(b) andE_(c) is already known from the four-point impedance measurement, theremaining impedance can be halved to obtain an estimate of theindividual electrode/tissue interface impedance. Thus, the presentembodiment makes it possible to identify the contributions to totalimpedance and also possible to identify mechanisms leading to impedancevariations. It is further possible to display the stimulation pulsevoltage measured on the current and the voltage electrode pairs.

Thus, the four-point intracochlea impedance measurement described withreference to the system of FIGS. 1a and 1b gives the same cochlearimplant functional information such as identifying instances of out ofcompliance or short/open circuited electrodes, when measuring thevoltage over the current stimulating electrodes at the current source.Moreover, the embodiment of FIGS. 1a and 1b also provides informationabout the tissue impedance when measuring the voltage over the voltagemeasuring electrodes E_(b) and E_(c). The tissue impedance providesinformation about the biological condition and reaction of the tissueduring current stimulation. This is significant information that can beused for intracochlea tissue diagnosis and/or study.

Moreover, the measurement method of FIGS. 1a and 1b allows measurementof the tissue impedance at different current levels, and may allowdetection of the threshold stimulation level. In tum, automation of themapping process for customizing the cochlear implant to the particularrecipient may be assisted by such information.

By providing for measurement of the voltage between two measuringelectrodes which are not used to apply the stimulus, the above discussedembodiment, provides for measurement of a voltage which arises almostentirely from the tissue impedance between the measuring electrodes inresponse to the stimulus, and/or from the voltage potential distributionwithin the tissue. In particular, the present embodiment provides for avoltage measurement which is substantially unaffected by any voltagearising from tissue/electrode interface impedance. The measured tissueimpedance, determined by comparing the measured voltage to the deliveredcurrent, in tum may provide information about the biological conditionand reaction of the tissue during and/or after current stimulation.Moreover, embodiments of the invention may in tum provide fordetermination of the electrode surface-to-tissue impedance, by using themeasuring electrodes as stimulating electrodes, referred to herein as atwo point measurement.

In some embodiments, a change in tissue response identified over time oridentified in response to differing stimuli may be indicative of athreshold at which the respective stimuli caused a neural response. Forexample, the stimulus may be altered in a stepwise fashion to find athreshold stimulus level (T level) at which neural responses firstarise. Similarly, the stimulus may be altered in a stepwise fashion inorder to determine a maximum comfort level (C level) at which a sumtotal of neural responses caused by stimuli along the length of theauditory nerve exceeds a patient comfort level.

An embodiment will now be described that provides automated tissueimpedance monitoring and re-mapping. This embodiment provides a way ofdeducing changes in T and C levels more accurately than before bymeasuring both the four point impedance at an electrode and its voltageduring stimulation on another electrode.

The system of this embodiment periodically measures the four pointimpedance at an electrode and its voltage during stimulation on anotherelectrode. The measured values are then used to calculate the predictedchange in current flowing over the nerve. The T and C levels are thenchanged in inverse proportion to the change in current flowing over thenerve in order to compensate for the new stimulus conditions. The goalof such automated updating of the device T and C parameters is toprevent the recipient's sound perception from changing for the negativewhen tissue impedance (current distribution) changes, as the appropriatestimulation current change is performed automatically without requiringclinician re-fitting of the device.

In this embodiment, impedance/potential measurements are taken for allelectrode combinations of stimulation pair, and in each instance for allelectrode combinations of measurement pair. The current flowing over theauditory nerve at each electrode is then be determined by reference tothe modiolus current. The self-monitoring device then identifies whichif any stimulation electrodes should be re-mapped. The remapping processcan be conducted either by the patient, after a prompt from the system,or automatically. For example, the initiation of re-mapping may simplycomprise the device indicating to the user that re-mapping is required,for example by illuminating a LED on the external component of theimplant or by playing back a perceivable recorded message via theimplanted electrodes and auditory nerve. Once the user has been alertedto the need for remapping, such re-mapping may be carried out manuallyby the user or a clinician. Alternatively the initiated re-mapping maybe conducted by the device, and may comprise the device altering Tlevels and/or C levels stored by the device by an amount commensuratewith the identified change in tissue response, and may even be performedwithout the user being made aware that re-mapping is being performed.

In an embodiment, the measurements of tissue response are obtainedregularly, for example periodically, throughout the lifetime of thedevice. The measurements of tissue response may comprise tissueimpedance measurements, whether obtained from stimulating electrodes ina two point measurement technique or obtained from non-stimulatingelectrodes in a four point measurement technique such as the method ofthe first aspect of the present invention. Additionally oralternatively, the measurements of tissue response may comprise residualpotential measurements arising from and measured following a tissuestimulus. The residual potential measurements may be obtained by a twopoint measurement technique, and/or by a four point measurementtechnique for example in accordance with the method of the third aspectof the invention. The measurements of tissue response may additionallyor alternatively comprise estimation of modiolus currents performed inaccordance with the method of the fourth aspect of the presentinvention.

A diagram showing an equivalent circuit of the cochlea when subjected tomonopolar stimulation is shown in FIG. 2. This is used to calculate thecurrents flowing in the modiolus impedances, Z_(m), as follows.

First, four point impedance measurements are made for all electrodesalong the array. This involves passing current through electrodes n andn+3 and simultaneously measuring the voltage between electrodes n+1 andn+2. This is done for all electrodes on the array (e.g., values of nfrom 1 to 19 for a 22 electrode array). Given that the cochlea is aperilymph-filled cavity encased in bone, and that perilymph has a lowresistivity compared with bone, the impedances within the cochlea, Z_(i)and Z_(t), are much smaller than the impedances within the bone, Z_(m).Therefore it is a reasonable approximation that the four point impedancevalues obtain in the above manner give the approximate values for thetissue impedances, Z_(t).

Next, a current is passed between electrode 1 and the monopolarelectrode and at the same time the voltages on electrodes 2 to 22 (for a22 electrode array) are measured. Then current is passed betweenelectrode 2 and the monopolar electrode and the voltage on allelectrodes other than electrode 2 is measured. This is repeated on allelectrodes to produce a table of voltages. It is possible to take eachmeasurement in a few tens of microseconds in modern cochlear implants sothat the whole table can be compiled in a fraction of a second.

Subsequently, from the table of voltages and the four point impedances,the currents flowing in the tissue impedances, Z_(t), are calculatedwhich in turn gives the currents in the modiolus impedances Z_(m). Thesecurrents are determined by noting that when current is passed betweenelectrode 1 and the monopolar electrode the current flow in tissueimpedance Z_(tn,n+1) is simply the voltage difference measured betweenelectrodes n and n+1 divided by the four point impedance, Z_(tn,n+1).That is,In _(,n+1)=(V _(n) −V _(n+1))/Z _(tn,n+1)where In_(n+1) is the current flowing in the tissue impedance Z_(tn,n+1)between electrodes n and n+1, V_(n) is the voltage measured on electroden, V_(n+1) is the voltage measured on electrode n+1, and Z_(tn,n+1) isthe four point impedance measured between electrodes n and n+1.

Using the model in FIG. 2 it is then possible to derive the currentflowing in the modiolus impedances, Z_(mn), because this will be thedifference between the current I_(n−1,n) and the current I_(n,n+1). Thatis,I _(mn) =I _(n−1,n) −I _(in,n+1)where I_(mn) is the current flowing into the modiolus impedance Z_(mn)at electrode n, I_(n−1,n), n is the current flowing in the tissueimpedance Z_(tn−1,n) between electrodes n−1 and n, and I_(n,n+1) is thecurrent flowing in the tissue impedance Z_(tn,n+1) between electrodes nand n+1.

The current flowing in these modiolus impedances Z_(mn) are important asthey approximate the current flowing over the nerve and are likely to beclosely related to the percept they induce for the user. A sketch oftypical voltages measured while current is passed between electrode 10and the monopolar electrode is show in FIG. 3a , while a sketch showingthe corresponding modiolus current is shown in FIG. 3 b.

Curves similar to FIG. 3b are also determined for stimulation currentapplied to each electrode other than electrode 10. A set of 22 curves istherefore obtained representing the current flow into the modiolus (andover the nerve) for monopolar stimulation applied for all 22 electrodes.These curves give a measure of the current flowing across the auditorynerve. In this embodiment, an original set of such curves is obtained atthe time the recipient had their T and C levels set, and stored in thedevice. A new set of curves would then be periodically remeasuredautomatically.

Such re-measurement may be done without alerting the recipient, by usinglevels of stimulation current below the hearing threshold for therecipient. As tissue normally behaves linearly with stimulation current,the curves established at a subthreshold current level can for manypurposes be scaled proportionally to any stimulation current.

These remeasured curves can be compared against the originally measuredcurves. Adjustments to the recipient's T and C levels can then be madeas follows. T and C levels are initially set for the recipient asnormal. At the same time the set of curves as described above aremeasured. Once the recipient leaves the clinic the curves areautomatically remeasured periodically and the T and C levels areadjusted based on any changes to the curves, in a predefined way. Forexample, a simple formula to determine the new T level for a singleelectrode n, based on the recorded impedance for that pair could be asfollows:

$T_{{new},n} = {T_{{original},n}*\frac{I_{m,{peak},n,{original}}}{I_{m,{peak},n,{new}}}}$where T_(new,n)=the new value of T level for electrode n to be used inthe recipient's map, T_(original,n)=the original value of therecipient's T level for electrode n measured by a clinician,I_(m,peak,n,original)=the new peak modiolus current for electrode n(i.e. the highest value of the curve for electrode n) calculated sometime after the original T level was set, and I_(m,peak,n,original)=thepeak modiolus current for electrode n (i.e. the highest value of thecurve for electrode n) measured when the original T level was set.

To update C level, it is noted that the C level perceived by therecipient is more likely to be related to the sum of current flow acrossall electrodes. Therefore in this embodiment the formula used to derivethe new C level is:

$C_{{new},n} = {C_{{original},n}*\frac{\sum_{{all}\mspace{14mu}{electrodes}}I_{m,{original},n}}{\sum_{{all}\mspace{14mu}{electrodes}}I_{m,{new},n}}}$where C_(new,n)=the new value of C level for electrode n to be used inthe recipient's map, C_(original,n)=the original value of C level forelectrode n measured by the clinician, Σ_(all electrodes)I_(m,new,n)−the sum of all I_(m) values for stimulation on electrode nas measured some time after the original c level was set, andΣ_(all electrodes) I_(m,original,n)=the sum of all I_(m) values forstimulation on electrode n as measured when the original C level wasset.

A schematic diagram of a cochlear implant system comprising an externalspeech processor and implant operable to apply the proposed mappingprocess is shown in FIG. 4. The implant's antenna coil AI is connectedto the implant's power supply circuitry PSC and the implant'sreceiver/demodulator circuitry R/D. The R/D drives the implant'sstimulation circuitry S. The implant's measurement circuitry MC obtainsmeasurements from the cochlea as described in the preceding, andcommunicates with the implant's modulator/transmitter circuitry M/T.

The implant's current source CS, power supply rail V_(dd), currentstimulation electrodes (stimulation pair) E_(a) and E_(d), voltagemeasurement electrodes (measurement pair) E_(b) and E_(c), switchesS_(aA) and S_(aB), S_(dA) and S_(dB), S_(bA) and S_(bB), and S_(cA) andS_(cB), differential voltage measurement circuitry V, and switchesS_(bV) and S_(cV) are as described previously with respect to FIG. 1.

The external speech processor comprises antenna coil ASP, microphone M,amplifier circuitry A and speech processor circuitry SP.

FIG. 5 illustrates the shape of the current pulse used for cochleaneuron stimulation. I_(s) is a current stimulation pulse (pulseamplitude), Ph1 is Phase 1 of the current stimulation pulse (pulseduration), Ph2 is Phase 2 of the current stimulation pulse (pulseduration) and IPG is the interphase gap (interphase gap duration).

The speech processor is inductively coupled with the implant via RF linkand provides the implant with power and data for stimulation andmeasurement. The speech processor also receives data such as measurementresults from the implant via the RF link.

Any tissue impedance change and current profile change in I_(m) can bedetected by the four point impedance measurement circuitry and voltagemeasurement circuitry. Such a change may be indicative of changed T or Clevels due to changed stimulation current distribution. The measuredvalues are transmitted to the speech processor from the implant, and canbe used for adjustment of the T and/or C level parameters stored by thedevice. The speech processor will thereafter transmit appropriatestimulus data to the implant which will adjust the amplitude of thestimulation current to compensate for the measured change. Ideally, thiscompensation minimizes or avoids any change in the patient's perceptionresulting from the tissue impedance change. The T/C parameters can beadjusted automatically by an appropriate algorithm of the processor, ormanually by the patient or a clinician.

The preceding embodiment thus monitors the tissue response for changeswhich may occur over time, by applying a standard test stimulus to thetissue and identifying changes over time in measurements obtained duringsuch a stimulus.

In a second embodiment, tissue measurements may be obtained in order toobtain a profile of the tissue response with respect to changes instimulus. In this embodiment, a two point voltage measurement isobtained from the stimulation electrodes during the interphase gap.During the interphase gap two point measurement, the electrodes arefloating, disconnected from the stimulation circuitry. This two pointmeasurement obtains a voltage which arises from the double layerpotential at each electrode/tissue interface and from the residualhearing neurons/tissue potential (charge) between the stimulationelectrodes. Also during the interphase gap, a four point voltagemeasurement is obtained, being the voltage across a pair of intracochleameasurement electrodes located between the stimulation electrodes. Thefour point measurement provides information about the residual hearingneurons/tissue charge, with the substantial absence of the double layerpotential at each electrode/tissue interface. Together, the two pointand four point measures enable the double layer potential and the tissuepotential to be separately determined

In the second embodiment, desired ranges or values of stimulusparameters are determined as follows.

First, a four point measurement of the hearing neurons/tissue impedanceis performed during Phase 1 of the stimulation. This is achieved duringPhase 1 by switches S_(aA) and S_(dB) being switched “ON” while allother switches to the power supply rail V_(dd) and the current source CSare switched “OFF” (see FIG. 1). The stimulation current flows from thepower supply rail V_(dd) through electrode E_(a), cochlea neurons/tissuelocated between electrodes E_(a) and E_(d), and electrode E_(d) to theCurrent Source (CS). The impedance of the hearing neurons/tissue locatedbetween the stimulation electrodes E_(a) and E_(d) can be measured (fora particular hearing neurons/tissue segment) by the voltage measurementelectrodes E_(b) and E_(c) connected to a differential voltagemeasurement circuitry V through switches S_(bV) and S_(cV).

Second, a four point measurement of the hearing neurons/tissue potentialresponse during the interphase gap is obtained. To obtain thismeasurement, during the interphase gap all switches to the power supplyrail V_(dd) and the current source CS are switched “OFF.” The hearingneurons/tissue potential response is measured by electrodes E_(b) andE_(c) connected to a differential voltage measurement circuitry Vthrough switches S_(bV) and S_(cV).

Third, a four point measurement of the hearing neurons/tissue impedanceis obtained during Phase 2 stimulation. To obtain this measurement,during Phase 2 switches S_(dA) and S_(aB) are switched “ON” while allother switches to the power supply rail V_(dd) and the current source CSare switched “OFF.” The stimulation current flows from the power supplyrail V_(dd) through electrode E_(d), cochlea neurons/tissue locatedbetween electrodes E_(d) and E_(a), electrode E_(a) to the CurrentSource (CS). The impedance of the hearing neurons/tissue located betweenthe stimulation electrodes E_(d) and E_(a) is measured (for a particularhearing neurons/tissue segment) by the voltage measurement electrodesE_(b) and E_(c) connected to differential voltage measurement circuitryV through switches S_(bV) and S_(cV).

Finally, a two point measurement of the electrode polarization potentialis obtained during the interphase gap. This is obtained by applying afurther biphasic stimulus on electrodes E_(b) and E_(c). During Phase 1,switches S_(bA) and S_(cB) are switched “ON” while all other switches tothe power supply rail V_(dd) and the current source CS are switched“OFF.” The stimulation current flows from the power supply rail V_(dd)through electrode E_(b), cochlea neurons/tissue located betweenelectrodes E_(b) and E_(c), electrode E_(c) to the Current Source (CS).As a result of the current flow through electrodes E_(b) and E_(c),their respective capacitive electrode/tissue interfaces are polarizing.During the interphase gap all switches to the power supply rail V_(dd)and the current source CS are switched “OFF.” The polarization potentialof electrodes E_(b) and E_(c) is then measured by the differentialvoltage measurement circuitry V connected to the polarized electrodesE_(b) and E_(c) through switches S_(bV) and S_(cV). During Phase 2,switches S_(cA) and S_(bB) are switched “ON” while all other switches tothe power supply rail V_(dd) and the current source CS are switched“OFF.” The charge balancing phase 2 stimulation current flows from thepower supply rail V_(d)d through electrode E_(c), cochlea neurons/tissuelocated between electrodes E_(c) and E_(b), electrode E_(b) to theCurrent Source (CS), de-polarizing the tissue interfaces of electrodesE_(b) and E_(c). This measurement allows the electrode double layercapacitance formed at the interface electrode/tissue due to stimulationcurrent flow to be calculated.

The four types of measurement described above are conducted fordifferent stimulation pulse frequencies, by varying the duration of thebiphasic stimulation pulse, and are also conducted for varyingstimulation amplitudes by linearly increasing the stimulation current.Such stimulation parameter variations enable a profile of tissueresponse with respect to varying stimulation to be obtained. Suchprofiles can then be obtained for each combination of electrodestimulation pair and electrode measurement pair giving a cochleaimpedance distribution map.

The results of such measurements allow real time automated mappingand/or adaptive stimulation to be performed based on the tissueimpedance measurement, to optimize the recipient's sound perception.

In the above discussed embodiments, the stimulating electrodes comprisea stimulating electrode pair, however an alternative number ofstimulating electrodes may be used. For example, in the embodiment ofFIGS. 1a and 1b , the two measuring electrodes are interposed betweenthe stimulating electrode pair, to provide for a measurementconfiguration in which the measuring electrodes are in a region of largevoltage gradient and such that a voltage differential between themeasuring electrodes is large. However, in alternative embodiments, theor further measuring electrodes may be positioned to one side of thestimulating electrodes, provided that a measurable voltage differentialarises across the measuring electrodes in response to the stimulus. Suchlaterally positioned measuring electrodes may be particularly useful inproviding information regarding the voltage distribution from thestimulated tissue between the stimulating electrodes to thenon-stimulated tissue in the vicinity of the laterally positionedmeasuring electrodes. Such information may assist in investigating thebiological condition of the intracochlea tissue.

All documents, patents, journal articles and other materials cited inthe present application are hereby incorporated by reference.

It will be appreciated by persons skilled in the art that numerousvariations and/or modifications may be made to the invention as shown inthe specific embodiments without departing from the spirit or scope ofthe invention as broadly described. For example, the techniques of thepresent invention may be applied in conjunction with neural responsetelemetry. The present embodiments are, therefore, to be considered inall respects as illustrative and not restrictive.

The invention described and claimed herein is not to be limited in scopeby the specific preferred embodiments herein disclosed, since theseembodiments are intended as illustrations, and not limitations, ofseveral aspects of the invention. Any equivalent embodiments areintended to be within the scope of this invention. Indeed, variousmodifications of the invention in addition to those shown and describedherein will become apparent to those skilled in the art from theforegoing description. Such modifications are also intended to fallwithin the scope of the appended claims.

What is claimed is:
 1. A method, comprising: applying an electricalstimulus to tissue using at least two stimulating electrodes of animplantable system; after application of the stimulus, performing a twopoint measurement between the stimulating electrodes to determine aresidual two point potential between the stimulating electrodesresulting from the electrical stimulus; after application of thestimulus, performing a four point measurement between twonon-stimulating electrodes to determine a residual four point potentialbetween the non-stimulating electrodes resulting from the electricalstimulus; comparing the measured residual two point potential to themeasured residual four point potential; determining, based on thecomparison, at least one of a residual tissue potential and a residualelectrode/tissue interface potential associated with one or more of thestimulating electrodes; and adjusting operation of the implantablesystem based on the least one of the residual tissue potential and theresidual electrode/tissue interface potential.
 2. The method 1, whereinthe two non-stimulating electrodes are a pair of electrodes locatedbetween the stimulating electrodes.
 3. The method of claim 1, whereinperforming the two point measurement between the stimulating electrodesincludes: open circuiting the stimulating electrodes.
 4. The method ofclaim 1, wherein the electrical stimulus is a biphasic stimuluscomprising first and second pulses of opposite polarity and aninter-phase gap between the first and second pulses, and wherein the twopoint measurement and the four point measurement are performed duringthe inter-phase gap.
 5. The method of claim 1, wherein the two pointmeasurement obtains a measure of a double layer potential at eachelectrode/tissue interface of the stimulating electrodes and of a tissuepotential between the stimulating electrodes.
 6. The method of claim 5,wherein the four point measurement provides information about the tissuecharge between the stimulating electrodes with the substantial absenceof the double layer potential at each electrode/tissue interface of thestimulating electrodes.
 7. The method of claim 1, wherein determining atleast one of a residual tissue potential and a residual electrode/tissueinterface potential associated with one or more of the stimulatingelectrodes, comprises: determining, based on the comparing of themeasured two point potential to the measured four point potential, aresidual tissue potential of the tissue between the stimulatingelectrodes.
 8. The method of claim 1, wherein determining at least oneof a residual tissue potential and a residual electrode/tissue interfacepotential associated with one or more of the stimulating electrodes,comprises: determining, based on the comparing of the measured two pointpotential to the measured four point potential, a double layer potentialat each electrode/tissue interface of the stimulating electrodes.
 9. Themethod of claim 1, wherein the stimulating electrodes comprise astimulating electrode pair.
 10. The method of claim 1, wherein theimplantable system is a cochlear implant system.
 11. A cochlear implantsystem, comprising: an implantable electrode array comprising aplurality of intracochlea electrodes; and a controller configured to:apply an electrical stimulus to intracochlea tissue using stimulatingelectrodes selected from the plurality of intracochlea electrodes, afterapplication of the stimulus, measure a residual two point potentialbetween the stimulating electrodes resulting from the electricalstimulus, after application of the stimulus, measure a residual fourpoint potential between two non-stimulating electrodes resulting fromthe electrical stimulus, compare the measured two point potential to themeasured four point potential, determine, based on the comparison, atleast one of a residual tissue potential and a residual electrode/tissueinterface potential associated with one or more of the stimulatingelectrodes, and adjust operation of the cochlear implant system based onthe least one of the residual tissue potential and the residualelectrode/tissue interface potential.
 12. The cochlear implant system ofclaim 11, wherein the two non-stimulating electrodes are a pair ofelectrodes located between the stimulating electrodes.
 13. The cochlearimplant system of claim 11, wherein to perform the two point measurementbetween the stimulating electrodes, the controller is configured to:open circuit the stimulating electrodes.
 14. The cochlear implant systemof claim 11, wherein the electrical stimulus is a biphasic stimuluscomprising first and second pulses of opposite polarity and aninter-phase gap between the first and second pulses, and wherein themeasurement of the residual two point potential and the measurement ofthe residual four point potential are performed during the inter-phasegap.
 15. The cochlear implant system of claim 11, wherein themeasurement of the residual two point potential provides informationabout a double layer potential at each electrode/tissue interface of thestimulating electrodes and of a tissue potential between the stimulatingelectrodes.
 16. The cochlear implant system of claim 15, wherein themeasurement of the residual four point potential provides informationabout a tissue charge between the stimulating electrodes with thesubstantial absence of the double layer potential at eachelectrode/tissue interface of the stimulating electrodes.
 17. Thecochlear implant system of claim 11, wherein determine at least one of aresidual tissue potential and a residual electrode/tissue interfacepotential associated with one or more of the stimulating electrodes, thecontroller is configured to: determine, based on the comparison of theresidual two point potential to the residual four point potential, aresidual tissue potential of the tissue between the stimulatingelectrodes.
 18. The cochlear implant system of claim 11, whereindetermine at least one of a residual tissue potential and a residualelectrode/tissue interface potential associated with one or more of thestimulating electrodes, the controller is configured to: determine,based on the comparison of the residual two point potential to theresidual four point potential, a double layer potential at eachelectrode/tissue interface of the stimulating electrodes.
 19. Thecochlear implant system of claim 11, wherein the stimulating electrodescomprise a stimulating electrode pair.
 20. A method, comprising:applying an electrical stimulus to tissue using at least two stimulatingelectrodes of an implantable system; following initial application ofthe electrical stimulus, performing a two point measurement between thestimulating electrodes; following initial application of the electricalstimulus, performing a four point measurement between twonon-stimulating electrodes; comparing a result of the two pointmeasurement to a result of the four point measurement; determining,based on the comparison, at least one of a residual tissue potential ofthe tissue between the stimulating electrodes and a double layerpotential at each electrode/tissue interface of the stimulatingelectrodes; and adjust operation of the implantable system based on theat least one of the residual tissue potential of the tissue between thestimulating electrodes and the double layer potential at eachelectrode/tissue interface of the stimulating electrodes.
 21. The methodof claim 20, wherein the two non-stimulating electrodes are a pair ofelectrodes located between the stimulating electrodes.
 22. The method ofclaim 20, wherein the electrical stimulus is a biphasic stimuluscomprising first and second pulses of opposite polarity and aninter-phase gap between the first and second pulses, and wherein the twopoint measurement and the four point measurement are performed duringthe inter-phase gap.
 23. The method of claim 20, wherein the two pointmeasurement is a residual two point potential between the stimulatingelectrodes and the four point measurement is a residual four pointpotential between the non-stimulating electrodes.
 24. The method ofclaim 20, wherein the two point measurement is a two point voltagemeasurement and the four point measurement is a four point voltagemeasurement.